Regulatory Affairs Officer-Regulated Markets (Kurla)

Flamingo Pharmaceuticals; Mumbai; In loco; INR 700.000 - 1.200.000; Tempo pieno

Descrizione del lavoro

Flamingo Pharmaceuticals in Mumbai, India, seeks a Regulatory Affairs professional with experience in regulated markets (EU/US) to manage pre-approval filings and new marketing authorizations. You will review technical documents, prepare Type IA/IB/II variations, and coordinate submissions to regulators.

Excellent written and verbal English communication is essential to collaborate across teams and meet regulatory timelines.

Competenze

• Experience in Regulatory Affairs of Regulated Market.
• Strong English written and verbal communication.

Mansioni

• Regulatory affairs for regulated markets (EU/US) experience.
• Prepare pre-approval filings and new marketing authorizations.
• Submit new dossier submissions to regulatory agencies.
• Review technical documents for submissions.
• Prepare Type IA/IB/II variations and license variations/renewals.

Conoscenze

Regulatory affairs

Regulated markets

English communication

Descrizione del lavoro

• Should have exp in Regulated(EU /US)
• Pre-approval filings New marketing authorizations
• New dossier submissions to regulatory agency
• Review technical documents
• prepare Type IA /IB/II variations
• prepare submissions license variations & renewals

Required Candidate profile

Candidates having experience in Regulatory Affairs of Regulated Market should only apply

Excellent written and verbal English communication

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